Development and Evaluation of an Automated Manual Resuscitator-Based Emergency Ventilator-Alternative

Abstract

Mass casualty incidents such as those that are being experienced during the novel coronavirus disease (COVID-19) pandemic can overwhelm local healthcare systems, where the number of casualties exceeds local resources and capabilities in a short period of time. The influx of patients with lung function deterioration as a result of COVID-19 has strained traditional ventilator supplies. To bridge the gap during ventilator shortages and to help clinicians triage patients, manual resuscitator devices can be used to deliver respirations to a patient requiring breathing support. Bag-valve mask (BVM) devices are ubiquitous in ambulances and healthcare environments, however require a medical professional to be present and constantly applying compression to provide the patient with respirations. We developed an automated manual resuscitator-based emergency ventilator-alternative (AMREV) that provides automated compressions of a BVM in a repetitive manner and is broadly compatible with commercially-available BVM devices approximately 5 inches (128 mm) in diameter. The AMREV device relieves the medical professional from providing manual breathing support and allows for hands-free operation of the BVM. The AMREV supports the following treatment parameters: 1) adjustable tidal volume (VT), 2) positive end-expiratory pressure (PEEP) (intrinsic and/or external), 3) 1:1 inspiratory: expiratory ratio, and 4) a controllable respiratory rate between 10-30 breaths per minute. The relationship between the inherent resistance and compliance of the lung and the delivered breaths was assessed for the AMREV device. Adjustable VT of 110-700 ml was achieved within the range of simulated lung states. A linear increase in mean airway pressure (Paw), from 10-40 cmH2O was observed, as the resistance and compliance on the lung model moved from normal to severe simulated disease states. The AMREV functioned continuously for seven days with less than 3.2% variation in delivered VT and Paw. Additionally, the AMREV device was compatible with seven commercially-available BVM setups and delivered consistent VT and Paw within 10% between models. This automated BVM-based emergency-use resuscitator can provide consistent positive pressure, volume-controlled ventilation over an extended duration when a traditional ventilator is not available. True ventilator shortages may lead to manual resuscitators devices such as the AMREV being the only option for some healthcare systems during the COVID-19 pandemic.